In this month's newsletter ..
- Familiarize yourself with the recent updates to the AMCP Format 5.0 for Formulary Submissions
- Unlock eDossiers with innovative tools to help you navigate like a pro
- Cheers to 5 years: Celebrate a legacy of innovation with FormularyDecisions
- Read a recap of the Afternoon Bubble Tea networking event and the AMCP Foundation P&T Competition at last month’s AMCP Annual
- Explore Metasearch articles and Product Snapshots this month to raise awareness for cystic fibrosis awareness month
- Register for the upcoming AMCP Webinar hosted by FormularyDecisions, “Bracing for the Impact of Biosimilars: Navigating Terrain in the U.S. Market Landscape”
Recent Update to the AMCP Format for Formulary Submissions
The Academy of Managed Care Pharmacy (AMCP) Format serves as guidance for the development of dossiers for manufacturers to provide to healthcare decision makers (HCDMs) as a comprehensive and standardized framework of clinical and economic evidence and information to support formulary consideration.
In April 2024, AMCP released Version 5.0 of the AMCP Format for Formulary Submissions. Key updates to AMCP Format 5.0 include the following:
- Special content considerations for digital therapeutics
- More robust language to include health disparities
- Increased emphasis on inclusion of real-world evidence
- Brevity encouraged to streamline dossiers
- Add-on guidance for pre-approval information exchange (PIE)
The last AMCP Format revision (Version 4.1) was released in December 2019 and provided expanded guidance on pre-approval dossiers (for unapproved products and unapproved uses of approved products) to support PIE for early scientific dialogue between manufacturers and HCDMs.
Click below to see the full details of the AMCP Format 5.0.
Unlocking eDossiers
Innovative tools to help you navigate like a pro
Leverage the innovative tools from the video tutorial to help you navigate eDossiers like a pro. See below for links to the product pages with eDossiers that were posted or updated within the last 60 days. On any product page, you have the option to access the specific eDossiers by submitting an eRequest. Log into FormularyDecisions today to view all eDossiers available.
PDUFA date |
Pipelinea product name |
|
09/26/2024 |
|
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10/11/2024 |
|
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05/31/2024 |
|
|
05/31/2024 |
|
|
03/31/2024 |
FDA approval date* |
Product name |
FDA-approved indicationb |
|
8/16/2023 |
RA, JIA, PsA, AS, CD, UC, Ps, HS, UV |
|
|
01/12/2024 |
Melanoma, NSCLC, HNSCC, cHL, PMBCL, urothelial cancer, MSI-H or dMMR, CRC, gastric cancer, esophageal cancer, cervical cancer, HCC, BTC, MCC, RCC, endometrial carcinoma, TMB-H cancer, cSCC, TNBC |
|
|
01/10/2023 |
Asthma |
|
|
07/23/2020 |
BREZTRI AEROSPHERE® (budesonide, glycopyrrolate, and formoterol fumarate)4 |
COPD |
|
09/01/2022 |
CIC |
|
|
05/19/2023 |
DLBCL |
|
|
04/24/2003 |
Fabry disease |
|
|
12/18/2023 |
DEB, JEB |
|
|
12/15/2023 |
la/mUC |
|
|
10/20/2023 |
Meningococcal disease |
|
|
03/01/2024 |
NSCLC |
|
|
06/12/2022 |
Plaque psoriasis, PsA, CD |
|
|
02/17/2023 |
GA secondary to AMD |
|
|
12/20/2023 |
IgAN |
|
|
07/13/2020 |
Plaque psoriasis, PsA |
|
|
03/26/2024 |
PAH (WHO Group 1) |
|
|
03/10/2023 |
Migraines |
*For multi-indication products, the FDA-approved date for the most recent approved indication is listed
Key: AMD – age-related macular degeneration; AS – ankylosing spondylitis; BTC – biliary tract cancer; CD – Crohn’s disease; cHL – classical Hodgkin Lymphoma; CIC: chronic idiopathic constipation; COPD – chronic obstructive pulmonary disorder; CRC – colorectal cancer; cSCC – cutaneous squamous cell carcinoma; DEB – dystrophic epidermolysis bullosa; DLBCL – diffuse large B-cell lymphoma; dMMR –mismatch repair deficient; GA – geographic atrophy; HCC – hepatocellular carcinoma; HNSCC – head and neck squamous cell cancer; HS – hidradenitis suppurativa; IgAN – immunoglobulin A nephropathy; JEB – junctional epidermolysis bullosa; JIA – juvenile idiopathic arthritis; la/mUC – locally advanced or metastatic urothelial carcinoma; MCC – Merkel cell carcinoma; MSI-H – microsatellite instability-high; NSCLC – non-small cell lunch cancer; PAH – pulmonary arterial hypertension; PMBCL – primary mediastinal large B-cell lymphoma; PS – plaque psoriasis; PsA – psoriatic arthritis; RA – rheumatoid arthritis; RCC – renal cell carcinoma; TNBC – triple-negative breast cancer; TMB-H – tumor mutational burden-high; UC – ulcerative colitis; UV – uveitis; WHO – World Health Organization
Cheers to 5 years!
A legacy of innovation with FormularyDecisions
Partnering with AMCP
FormularyDecisions has been supporting AMCP Pre-approval Information Exchange (PIE) Webinars and the AMCP Foundation Annual National Student Pharmacist P&T Competition. AMCP PIE webinars create an opportunity to share preapproval information with healthcare decision makers to help plan for future approvals and associated early product reviews, coverage and reimbursement decisions, and budget forecasting. The AMCP Foundation National Student Pharmacist P&T Competition is an annual team event designed to provide an immersive experience in the skills necessary for effective formulary review and management. P&T Competition teams work together as if they are preparing for — and presenting to — a mock P&T Committee.Creating access to additional resources
In 5 years, FormularyDecisions has added an industry-recognized Biosimilar Hub, Cell & Gene Therapy Hub, Product Snapshots, Clinical Guideline Snapshots, Formulary Coverage Insights, and MyInsights Program Surveys and Feedback opportunities. Our skilled team of developers also improved the user experience by increasing the refresh speed and improving the user interface to reduce the time to navigate to the information you are looking for.As healthcare decision maker needs continue to evolve, FormularyDecisions will also consistently enhance and innovate to meet your product information needs. Stay tuned through the FormularyDecisions Connection newsletter for all the advancements coming.
In the meantime, we welcome any comments or feedback, so don't hesitate to contact us.
Connecting at AMCP Annual
We enjoyed connecting with you at AMCP Annual last month! Thank you to all who stopped by the Cencora booth at the Expo Hall, the FormularyDecisions kiosk to snap a photo, the Afternoon Bubble Tea networking event, and Cencora’s evening reception.
Almost 60 healthcare decision makers gathered in New Orleans to connect over your favorite local cuisines and discuss the challenges you are facing with managing high-cost treatments for rare diseases, including cell & gene therapies. We highlighted the newest additions to FormularyDecisions, including the Cell & Gene Therapy Hub and the latest Clinical Guideline Snapshots, that may help you in your search for information on high-cost treatments.
Left to right: Cynthia Thai with Bubbles the mascot (Cencora), Tasmina Hydery (Cencora), Jasmine Knight (Cencora), Thaiying Young (Cencora)
Announcement:
The AMCP Foundation P&T Competition winners
FormularyDecisions is proud to support the annual national student pharmacist P&T competition by serving as the digital platform for students, advisors, and judges to access the competition product eDossier. Out of the 55 schools of pharmacy who participated at the local level, 5 schools were selected to send their winning teams to New Orleans last month to compete nationally. Congratulations to the winning student teams and their advisors!
1st Place:
University of Connecticut
Ryan Shan, Gianni Contrera, Huiqiao (Melinda) Fan, Janette Wadolowski
Advisors: Christina Polomoff, Andrew Cournoyer, Daniel Shan, Glen Smyth, Jeffery Casberg, Joseph Honcz
2nd Place:
University of Minnesota
Dina Zheng, Vanessa Orcutt, Elizabeth Welter, Kelly Chies
Advisor: Joel Farley
3rd Place:
University of Illinois Chicago
Daniel Lee, Eddie Pallares, Leah Song, Sean Martin
Advisor: Margaret Byun
Cystic Fibrosis
According to the Cystic Fibrosis Foundation, there are close to 40,000 children and adults living with CF in the United States and an estimated 105,000 people have been diagnosed with CF across 94 countries. CF can affect people of every racial and ethnic group. Today, because of improved medical treatments and care, more than half of people with CF are age 18 or older. Many people with CF can expect to live healthy, fulfilling lives into their 30s, 40s, and beyond.18
Below are some links you can find in the Metasearch results section of the Cystic fibrosis page on FormularyDecisions:- Diagnosis and management of gastrointestinal manifestations in children with cystic fibrosis
- Explainable artificial intelligence for deep learning-based classification of cystic fibrosis lung changes in MRI
- What the future holds: cystic fibrosis and aging
Be sure to also reference available Product Snapshots on CF products. Product Snapshots, curated by clinical pharmacists at ForHealth Consulting team at UMass Chan Medical School, not only provide a high-level overview of the product, but they also include a summary of key clinical trials and Pharmacy & Therapeutics considerations.
Upcoming Webinars
Academy of Managed Care Pharmacy (AMCP) Webinar hosted by FormularyDecisions
Bracing for the Impact of Biosimilars: Navigating Terrain in the U.S. Market Landscape
Date: June 11, 2024
Time: 2-3 PM ET
Join this interactive, engaging, and informative discussion to discover the keys to thriving in the dynamic biosimilars landscape. In this session, you will gain practical insights on navigating regulatory challenges, seizing opportunities for collaboration, and communicating effectively with stakeholders. Stay ahead of the curve with up-to-date industry trends and expert strategies tailored to driving success in the U.S. biosimilars market.
Learning objectives:
- Review the U.S. biosimilars market landscape and the current legislative and regulatory environment.
- Identify key factors affecting payer uptake and provider adoption of biosimilars in the U.S.
- Explore challenges and opportunities associated with biosimilars for stakeholders across the healthcare continuum.
- Position yourself for success by leveraging expert strategies and insights to proactively address potential market challenges.
Click below for webinar details and to register through the AMCP website
